FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
740 SELECT
K Number: K150620
·
Decision May 8, 2015
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
32
Review Days
59
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Basic Information
- Device Name
- 740 SELECT
- K Number
- K150620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cas Medical Systems, Inc.
- Date Received
- March 10, 2015
- Decision Date
- May 8, 2015
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Cas Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Oct 21, 2019 | Substantially Equivalent |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | May 10, 2018 | Substantially Equivalent |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Apr 10, 2015 | Substantially Equivalent |
| K140430 | 740 SELECT | Jun 13, 2014 | Substantially Equivalent |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Apr 29, 2014 | Substantially Equivalent |
| K130411 | 740 SELECT | May 29, 2013 | Substantially Equivalent |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Apr 11, 2013 | Substantially Equivalent |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | Jan 26, 2012 | Substantially Equivalent |
| K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | Dec 23, 2010 | Substantially Equivalent |
| K091452 | FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) | Aug 21, 2009 | Substantially Equivalent |